Actively Recruiting
Acupuncture for POstoperative Gastric Emptying dElay (APOGEE): A Multicenter Randomized Controlled Trial
Led by Qilu Hospital of Shandong University · Updated on 2026-04-20
176
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
W
Weifang Yidu Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of acupuncture as a treatment for delayed gastric emptying that occurs after partial gastrectomy surgery. This multicenter, randomized, controlled trial includes adult patients who develop gastroparesis after surgery and aims to provide strong evidence on whether acupuncture can improve gastric motility, speed up gastric emptying, and relieve symptoms such as abdominal distension, nausea, and vomiting. Participants will be randomly assigned to one of two groups: an acupuncture group receiving active acupuncture alongside standard postoperative care, and a control group receiving sham acupuncture with standard care. Treatments are delivered by licensed acupuncturists who use standardized techniques. Both groups receive similar session durations and frequencies. The study also prohibits additional medications targeting gastroparesis beyond the standard protocol during the treatment period. Throughout the study, participants will be closely monitored with clinical data collection, imaging tests like gastric emptying scintigraphy and abdominal radiographs, symptom questionnaires including the Gastroparesis Cardinal Symptom Index, blood and gastric fluid samples, and nutritional assessments. Follow-ups occur at multiple time points up to 12 months post-treatment to assess recovery, symptom improvement, quality of life, and safety. Adverse events are carefully recorded and managed, ensuring participant safety over the course of the trial.
CONDITIONS
Brief Title
Acupuncture for Postoperative Gastric Emptying Delay
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years, regardless of sex
- Patients who have undergone partial gastrectomy
- Patients presenting with postoperative gastroparesis symptoms, confirmed by imaging or gastric emptying scintigraphy, and clinically diagnosed with gastroparesis
- No severe cardiac, hepatic, renal, or coagulation dysfunction
- No participation in other interventional clinical trials within the past month
- Able to provide written informed consent and comply with the treatment and follow-up procedures
You will not qualify if you...
- Severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or coagulation disorders
- Serious postoperative complications such as anastomotic leakage, gastrointestinal bleeding, severe infections, ascites, or intestinal obstruction
- Allergy to acupuncture or skin damage, infection, or severe scarring at needle sites preventing proper treatment
- Diagnosed psychiatric disorders, cognitive impairment, or inability to cooperate with treatment or follow-up
- Use of medications significantly affecting gastric motility within the past week that cannot be stopped
- Pregnant or breastfeeding women or individuals with special physiological conditions unsuitable for acupuncture research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until resolution of gastroparesis
Participants receive either active acupuncture or sham acupuncture combined with standard postoperative care to treat postoperative gastroparesis after partial gastrectomy.
Weekly visits during the treatment period
Duration - Up to 12 months
Participants are monitored for up to 12 months after treatment to assess recovery, symptom improvement, and safety.
Visits at 1, 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Qilu hospital
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
Z
zhibo Yan, PhD
W
wenbin Yu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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